1. Field of the Invention
The present invention generally relates to clinical trials. In particular, the present invention relates to configuring a clinical trial program to implement a particular protocol of a particular clinical trial.
2. Description of the Related Art
Before a new medical drug (e.g., pharmaceuticals) or device (e.g., surgical instruments or implants) may be dispensed to the public, the United States Food and Drug Administration (FDA) requires that the manufacturers of the pharmaceuticals, devices, instruments, or implants conduct extensive clinical trial research in order to demonstrate the clinical effectiveness, safety, and medical advantage of their products. Extensive and often complex clinical trial protocols are developed that define, for example, targeted demographics, proposed medications, patient regimens, forms for collection, types of statistically relevant data, the timing or order of events within the study, often even the layout of the reporting data, and the like. These protocols are often sufficiently complex that the protocols themselves receive FDA approval.
Once a protocol is developed and approved, companies design electronic data capture and data management solutions to manage the ever burgeoning amount of data gathered. In general, such data capture and data management solutions capture data from geographically disparate clinicians or study participants defining many points of data entry, potentially across many software and hardware platforms. Drawbacks of these systems include the costs associated with designing, customizing, and/or adapting particular proprietary data capture and data management systems to the ever changing needs presented with each new protocol of each new clinical trial. Thus, many of today's sponsors resort to highly-skilled technology personnel, such as computer programmers or system designers, to adapt their systems, particularly their database and data storage systems, to each protocol. Use of such personnel can be time-consuming, costly, difficult to replicate over somewhat trivial changes, and can lack scalability.
As one may suppose, manufacturers of the pharmaceuticals, devices, instruments, or implants invest millions of dollars conducting the foregoing clinical trials before they receive any revenue from a sale of their products. For example, a rough estimate may be as long as 12 to 15 years to bring a drug to market at a cost of over $800 million. Accordingly, sponsors are eager to lower the cost and complexity associated with clinical trials.